Cleared Traditional

K131157 - RANFAC BONE MARROW ASPIRATION NEEDLE

K131157 is the FDA 510(k) clearance for RANFAC BONE MARROW ASPIRATION NEEDLE by Ranfac, Corp.. It is a Class 2 Gastroenterology & Urology device (product code KNW) cleared through the Traditional 510(k) pathway after a 181-day FDA review.

K131157 · Ranfac, Corp. · Gastroenterology & Urology device
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Oct 2013
Decision
181d
Days
Class 2
Risk

K131157 is an FDA 510(k) clearance for the RANFAC BONE MARROW ASPIRATION NEEDLE. Classified as Instrument, Biopsy (product code KNW), Class II - Special Controls.

Submitted by Ranfac, Corp. (Avon, US). The FDA issued a Cleared decision on October 22, 2013 after a review of 181 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.1075 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Ranfac, Corp. devices

Submission Details

510(k) Number K131157 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 2013
Decision Date October 22, 2013
Days to Decision 181 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d slower than avg
Panel avg: 130d · This submission: 181d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KNW Instrument, Biopsy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1075
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KNW Instrument, Biopsy

All 111
Devices cleared under the same product code (KNW) and FDA review panel - the closest regulatory comparables to K131157.
Sertera Biopsy Device
K150169 · Hologic, Inc. · Aug 2015
Imbibe Aspirating XIA Taps
K143546 · Stryker Corporation · Mar 2015
IVAS 8 GAUGE BONE BIOPSY KIT
K141673 · Stryker Corporation · Sep 2014
ENCOR ENSPIRE BREAST BIOPSY SYSTEM
K111100 · C.R. Bard, Inc. · Jun 2011
FINESSE ULTRA BREAST BIOPSY SYSTEM DRIVER (BLUE, PINK)
K103359 · C.R. Bard, Inc. · Dec 2010
MAMMOTOME BIOPSY SYSTEM FOR MOLECULAR IMAGING
K093899 · Ethicon Endo-Surgery, LLC · Apr 2010